Ferring Adds Three New Studies to Non-Muscle Invasive Bladder Cancer Clinical Trial Program With ADSTILADRIN (nadofaragene firadenovec-vncg)

Ferring Pharmaceuticals today announced start up of new studies in the United States (U.S.) for three new ADSTILADRIN in BLadder cancEr (ABLE) clinical trials in patients with non-muscle invasive bladder cancer (NMIBC) with plans to expand select clinical trials outside of the U.S. later this year. ADSTILADRIN was approved by the U.S. Food and Drug Administration (FDA) in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

“ADSTILADRIN is the foundation of Ferring's leadership mission in the uro-oncology therapeutic category and our ambition is for it to become the new standard of care and the backbone therapy for patients across the NMIBC disease spectrum,” said Bipin Dalmia, Senior Vice President, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Embarking on a broad research and geographic expansion program is yet another demonstration of our commitment to the uro-oncology community, together with our significant manufacturing investments that recently enabled full availability of ADSTILADRIN to every appropriate U.S. patient who needs it.”

The addition of three new ABLE clinical trials to the existing multi-year ADSTILADRIN studies program will expand the body of evidence for the intravesical non-replicating gene therapy:

• ABLE-22: A Phase 2, randomized, multi-center, open label clinical study to evaluate the safety and efficacy of ADSTILADRIN alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in adult patients with high-grade BCG-unresponsive NMIBC.

• ABLE-32: A Phase 3b randomized, controlled clinical study to evaluate the safety and efficacy of ADSTILADRIN versus observation in patients with intermediate-risk NMIBC.

• ABLE-42: A Phase 4, multi-center, open-label clinical study to evaluate the efficacy of retreatment with ADSTILADRIN in previously-treated patients with high-grade BCG-unresponsive NMIBC with CIS with or without papillary tumors who had not responded to the product at the first three-month assessment.

“ADSTILADRIN is an established monotherapy treatment option for patients with BCG-unresponsive NMIBC disease, an area where patients’ treatment options have been severely limited for decades,” said Pierre-Yves Berclaz, M.D., Ph.D., Executive Vice President and Chief Science and Medical Officer, Ferring Pharmaceuticals. “These new trials underscore Ferring's commitment to create solutions for patients by enlarging the body of evidence for this novel nonreplicating gene therapy.”